Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

Draft scope assessment: unclear. Attached because the study's own record names FGFR2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.

Efficacy Evaluable Population (EEP): all participants who received ≥1 dose of pemigatinib and had a known FGF/FGFR alteration or, in the United States, were negative for FGF/FGFR alterations based on central genomics laboratory results. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.

→

secondary · POSTED

ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.

Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.

→

secondary · POSTED

ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.

→

secondary · POSTED

ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.

→

secondary · POSTED

PFS was defined as the length of time from the first dose of study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.

Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.

→

secondary · POSTED

DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) as assessed by an independent centralized radiological review committee to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method. Only participants with a CR or PR were analyzed.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id: NCT02924376
trial label: Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
applicability: unclear
applicability note: Attached because the study's own record names FGFR2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0000
source section id
NCT02924376-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
endpoint definition
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
time origin
up to 1527 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy Evaluable Population (EEP): all participants who received ≥1 dose of pemigatinib and had a known FGF/FGFR alteration or, in the United States, were negative for FGF/FGFR alterations based on central genomics laboratory results. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0001
source section id
NCT02924376-om-0001
source outcome index
1
endpoint
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
endpoint definition
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
time origin
up to 424 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0002
source section id
NCT02924376-om-0002
source outcome index
2
endpoint
ORR in All Participants With FGF/FGFR Alterations
endpoint definition
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
time origin
up to 1527 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0003
source section id
NCT02924376-om-0003
source outcome index
3
endpoint
ORR in Participants Negative for FGF/FGFR Alterations
endpoint definition
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
time origin
up to 143 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0004
source section id
NCT02924376-om-0004
source outcome index
4
endpoint
Progression-free Survival (PFS)
endpoint definition
PFS was defined as the length of time from the first dose of study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
time origin
up to 50.17 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0005
source section id
NCT02924376-om-0005
source outcome index
5
endpoint
Duration of Response (DOR)
endpoint definition
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) as assessed by an independent centralized radiological review committee to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
time origin
up to 47.11 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method. Only participants with a CR or PR were analyzed.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0000
arm key
OG000
arm label
Cohort A: FGFR2 Rearrangements or Fusions
regimen
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
108
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0000
arm key
OG001
arm label
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
regimen
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0000
arm key
OG002
arm label
Cohort C: Negative for FGF/FGFR Alterations
regimen
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0000
arm key
OG003
arm label
Other
regimen
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0001
arm key
OG000
arm label
Cohort A: FGFR2 Rearrangements or Fusions
regimen
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0001
arm key
OG001
arm label
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
regimen
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0001
arm key
OG002
arm label
Cohort C: Negative for FGF/FGFR Alterations
regimen
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0001
arm key
OG003
arm label
Other
regimen
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0002
arm key
OG000
arm label
Cohort A: FGFR2 Rearrangements or Fusions
regimen
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0002
arm key
OG001
arm label
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
regimen
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0002
arm key
OG002
arm label
Cohort C: Negative for FGF/FGFR Alterations
regimen
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
outcome key
om-0002
arm key
OG003
arm label
Other
regimen
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02924376-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
harm key
EG000
source section id
NCT02924376-ae
event group key
EG000
event group label
Cohort A: FGFR2 Rearrangements or Fusions
serious affected
46
serious at risk
108
other affected
108
other at risk
108
frequency threshold
5
collection period
up to 1584 days
event definition
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
harm key
EG001
source section id
NCT02924376-ae
event group key
EG001
event group label
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
serious affected
10
serious at risk
20
other affected
20
other at risk
20
frequency threshold
5
collection period
up to 1584 days
event definition
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
harm key
EG002
source section id
NCT02924376-ae
event group key
EG002
event group label
Cohort C: Negative for FGF/FGFR Alterations
serious affected
12
serious at risk
17
other affected
17
other at risk
17
frequency threshold
5
collection period
up to 1584 days
event definition
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
harm key
EG003
source section id
NCT02924376-ae
event group key
EG003
event group label
Other
serious affected
0
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
up to 1584 days
event definition
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma-truseltiq-a2b17d90
nct id
NCT02924376
harm key
EG004
source section id
NCT02924376-ae
event group key
EG004
event group label
Total
serious affected
68
serious at risk
147
other affected
147
other at risk
147
frequency threshold
5
collection period
up to 1584 days
event definition
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice